MAUDE Adverse Event Report: MAQUET SAS HLED; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568370953

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On 26th november, 2023 getinge became aware of an issue with one of surgical lights - hled 700i.It was stated that oil droplets were present under the stainless steel dust cover of the spring arm.According to the information provided by getinge technician there was a risk of oil dripping off the spring arm.We decided to report the issue in abundance of caution as any substance falling off into sterile field or during procedure may cause contamination.

Event Description

On 26th november, 2023 getinge became aware of an issue with one of surgical lights - hled 700.It was stated that oil droplets were present under the stainless steel dust cover of the spring arm.According to the information provided by getinge technician there was a risk of oil dripping off the spring arm.We decided to report the issue in abundance of caution as any substance falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

It appeared that the issue reported under manufacturer¿s reference number: (b)(4) (report number: 9710055-2023-00983) is a duplicate of the issue reported under manufacturer¿s reference number: (b)(4) (report number: 9710055-2023-00984).Therefore, the issue is evaluated under manufacturer¿s reference number: (b)(4) (report number: 9710055-2023-00984).The correction of b5 describe event and problem deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 26th november, 2023 getinge became aware of an issue with one of surgical lights - hled 700i.It was stated that oil droplets were present under the stainless steel dust cover of the spring arm.According to the information provided by getinge technician there was a risk of oil dripping off the spring arm.We decided to report the issue in abundance of caution as any substance falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event and problem: on 26th november, 2023 getinge became aware of an issue with one of surgical lights - hled 700.It was stated that oil droplets were present under the stainless steel dust cover of the spring arm.According to the information provided by getinge technician there was a risk of oil dripping off the spring arm.We decided to report the issue in abundance of caution as any substance falling off into sterile field or during procedure may cause contamination.

• Brand Name: HLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 18382860
• MDR Text Key: 331229007
• Report Number: 9710055-2023-00983
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568370953
• Device Catalogue Number: ARD568370953
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/03/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1